International reference: 6 US FDA recalls for this ingredient

CGMP DEVIATIONS (antiseptic)

Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes are listed as "mineral oil , petrolatum ". The inactive ingredients in the actual product are polyethylene glycol 400 , polyethylene glycol 4000. (antiseptic)

Chemical Contamination: FDA analysis found the product to contain methanol, acetaldehyde, and acetal above the limits. (antiseptic)

CGMP Deviations (antiseptic)

CGMP Deviations (antiseptic)

cGMP Deviations (antiseptic)

US-market enforcement records (OpenFDA), shown for reference - not specific to this product in Malawi.

Registered Malawi · PMRA

MISTDRESS COMBINATION PRODUCT SPRAY

ANTISEPTIC BANDAGE SPRAY

PMPB/PL351/88 SPRAY

What it does

Antiseptics are substances used to prevent infection by killing or inhibiting the growth of germs.

Commonly used for: prevention of infections in cuts and wounds, sanitizing skin before medical procedures

Read more in plain English ↓

Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

Ask about this medicine

Answers come only from this medicine's registration record, BNF monograph and interaction data - not medical advice.

Medicine sourcing is available in Kenya only. We don't sell or dispense medicines - licensed pharmacies do.

Sourcing - Kenya only

Registration & product details

Registration no.
PMPB/PL351/88
Registration date
23/01/2017
Expiry date
30/06/2015
Status
Registered
Active ingredient
ANTISEPTIC BANDAGE SPRAY
Dosage form
SPRAY
Strength
-
Pack size
-
Therapeutic class
-
Manufacturer / MAH
-
Applicant / LTR
-
Country of origin
-

Source: Pharmacy and Medicines Regulatory Authority · fetched 2026-04-21 17:37:41 · updated 2026-09-29 04:33:05

Disclaimer: This information is sourced from Pharmacy and Medicines Regulatory Authority (Malawi). Always consult a qualified healthcare professional before using any medication.

About antiseptic

Antiseptics are substances used to prevent infection by killing or inhibiting the growth of germs.

What it treats

  • prevention of infections in cuts and wounds
  • sanitizing skin before medical procedures

How it works

Antiseptics kill or stop the growth of bacteria, viruses, and fungi on the skin or surfaces.

Who it's for

Antiseptics are suitable for anyone needing to clean wounds or skin to prevent infection.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About bandage

Bandages are used to cover and protect wounds or injuries, helping to keep them clean and support healing.

What it treats

  • wound protection
  • support for sprains or strains
  • keeping dressings in place

How it works

Bandages provide a barrier against dirt and bacteria, helping to prevent infection and support the healing process.

Who it's for

Anyone with a minor injury, cut, or strain.

Cautions

  • • Ensure the bandage is not too tight to avoid cutting off circulation.
  • • Change the bandage regularly to keep the wound clean.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: antiseptic

Antiseptics are substances that inhibit the growth of microorganisms on living tissues and are commonly used to prevent infection during surgical procedures, wound care, and other applications where skin integrity is compromised. They work by disrupting the cellular structure of microbes, leading to cell death or inhibition of growth. Antiseptics can be found in various forms, including solutions, gels, and sprays, and are pivotal in clinical and home settings.

Indications

  • Prevention of infection in surgical procedures
  • Wound cleansing and management
  • Disinfection of skin prior to injections or invasive procedures
  • General hand hygiene
  • Management of minor burns and abrasions

Dosage

Children: For paediatric use, antiseptics should also be applied according to the manufacturer's guidelines with consideration for age, weight, and specific condition. Refer to the BNF for Children for detailed dosing recommendations.

Adults: For topical application, antiseptics should be used according to the manufacturer's instructions, typically applied to the affected area 1-3 times daily, depending on the specific product and clinical scenario.

Mechanism of action

Antiseptics exert their effects through various mechanisms, including disruption of the microbial cell membrane, denaturation of proteins, and interference with nucleic acid synthesis. For example, alcohols denature proteins and dissolve lipids, while iodine-based antiseptics release free iodine, which penetrates the cell wall of microorganisms, leading to cell death.

Pharmacodynamics

The pharmacodynamic profile of antiseptics varies by compound. Generally, they demonstrate a broad spectrum of antimicrobial activity against bacteria, fungi, and viruses. The efficacy depends on concentration, exposure time, and the presence of organic matter. Some antiseptics may also exhibit cytotoxic effects on human tissues at high concentrations, which limits their use in certain scenarios.

Pharmacokinetics

The pharmacokinetics of antiseptics largely depend on their formulation and mode of application. Most antiseptics are not absorbed systemically when applied topically, leading to localized effects. Their duration of action can vary, with some providing immediate antimicrobial activity while others may have residual effects after application. The elimination of antiseptics occurs through evaporation or degradation on the skin's surface.

Adverse effects

  • Skin irritation
  • Allergic reactions
  • Burning sensation
  • Dryness of the skin

Precautions

  • Should not be used on large areas of broken skin
  • Avoid contact with eyes
  • Use caution in patients with a history of allergic reactions to antiseptics

Pregnancy

Generally considered safe for topical use during pregnancy, but consult a healthcare provider.

Breast-feeding

Topical use is usually considered safe, but should be used with caution.

Storage

Store in a cool, dry place away from direct sunlight. Keep out of reach of children.

Formulations

  • Liquid solutions
  • Gels
  • Ointments
  • Wipes

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: bandage

A bandage is a strip of material used to bind a wound or to protect an injury. Bandages can be made from various materials such as cloth, gauze, or elastic, and are designed to provide support, absorb blood or exudate, and promote healing by keeping the area clean and protected from infection.

Indications

  • Wound protection
  • Support for sprains and strains
  • Control of bleeding
  • Post-surgical care
  • Absorption of exudate
  • Prevention of infection

Dosage

Children: Apply a suitable bandage to the affected area, ensuring it is secure but not overly tight. Change the bandage as needed to keep the wound clean and dry.

Adults: Apply a suitable bandage to the affected area, ensuring it is secure but not overly tight. Change the bandage as needed to keep the wound clean and dry.

Mechanism of action

Bandages function primarily through physical means. They provide compression to minimize swelling, protect the wound from external contaminants, and help to stabilize injured areas. Some bandages are designed to promote moisture retention to facilitate healing.

Pharmacodynamics

Bandages do not have pharmacological effects like drugs do, but they play a crucial role in the healing process by creating an optimal environment for tissue repair. They help reduce pain and discomfort by limiting movement around the injury and also contribute to hemostasis by controlling bleeding.

Pharmacokinetics

Bandages do not undergo pharmacokinetic processes such as absorption, distribution, metabolism, or excretion, as they are not pharmacological agents. Their effectiveness depends on proper application and maintenance of cleanliness and moisture balance at the wound site.

Storage

Store in a cool, dry place away from direct sunlight.

Formulations

  • Adhesive bandages
  • Gauze bandages
  • Elastic bandages
  • Compression bandages

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.